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Archive: TMF/eTMF Regulatory Agency Expectations, Inspections, and Findings
- Explain regulatory expectations regarding TMF/eTMF management
- Identify two recent regulatory findings directed at TMF/eTMF management
- Describe strategies for preparing effective CAPAs that address regulatory findings
- Discuss plan for preparing for a regulatory inspection
Who Should Attend
- Good Clinical Practice Auditors and Quality Assurance Directors
- Trial Master File Directors, Managers, and Coordinators
- Clinical Operations Directors and Trial Managers
- Records Management Team Members
Donna W. Dorozinsky, R.N., M.S.N., C.C.R.C.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.